Psychedelic Frontiers Series – Part 2: How Scientists Navigate Regulatory Storms to Advance Psychedelic Research
In Psychedelic Frontiers: Diverse Perspectives on a Mental Health Revolution, FTI Consulting experts embark on a journey to explore the various ways in which psychedelic medicine is perceived across different stakeholder groups, including the research community, medical and mental health providers, and political stakeholders. The series aims to underscore the nuances of communicating about psychedelic medicines with vested parties, especially in regard to the therapeutic potential of these substances amid the growing mental health crisis. Our first installment of the series explored the public perception of these substances, outlining how stigma and misinformation have hindered their therapeutic success. This installment focuses on the invaluable perspectives and contributions of the scientific community to psychedelic research, despite complex regulatory and public dynamics, in advancing the field.
Scientific Advancements
The resurgence of interest in psychedelics can be traced back to pivotal studies that have demonstrated their potential in treating various mental health conditions. Lately, MDMA-assisted therapy for post-traumatic stress disorder (PTSD) has garnered substantial attention, with studies demonstrating that MDMA can dramatically reduce PTSD symptoms even in patients who have not responded to traditional treatments.[1,2]
However, the optimism surrounding MDMA therapy recently faced a significant setback. In June 2024, scientific advisers to the U.S. Food and Drug Administration (FDA) voted overwhelmingly that the risks of MDMA treatment for PTSD outweigh the benefits.[3] The independent advisory committee’s decision, with a 9 to 2 vote against its efficacy and a 10 to 1 vote against its safety, highlights the challenges of assessing psychedelic drugs and underscores the FDA’s cautious approach toward psychiatric treatments.[4] Although this vote does not bind the FDA, the agency often follows the committee’s recommendations.[5] Regardless of this setback, there are still positive scientific developments that should be part of this ongoing discussion, such as non-hallucinogenic versions of psychedelic therapies that are proving to provide similar biochemical benefits without the hallucinogenic effect. These alternatives can address the scalability and clinical trial concerns that were raised during the vote.
Ethical Considerations in Psychedelic Research
As demonstrated by the issues identified with the MAPS research, the path to mainstream acceptance and application of psychedelics in medicine has several ethical considerations. One of the primary concerns is the potential for abuse and the risks associated with unsupervised use. Psychedelics are potent substances that can induce intense and sometimes overwhelming experiences; as such, ensuring that these substances are administered in controlled, therapeutic settings is essential to minimize risks and maximize clinical efficacy.[6]
Informed consent is another important ethical consideration in this field. Participants in psychedelic research must fully understand the potential risks and benefits, as well as the nature of the experiences they might encounter. Given the profound and sometimes unpredictable effects of psychedelics, obtaining truly informed consent while hallucinations are present can be challenging.[7] In addition, due to the hallucinogenic nature of psychedelic compounds, challenges arise regarding test subject awareness precisely because many can determine if they have been given the active compound or the placebo, which can undermine the results of the study due to the lack of a true control and test group.[8]
Moreover, the cultural and historical context of psychedelics cannot be ignored. Many indigenous communities have used these substances for centuries in traditional healing practices and religious ceremonies. Respecting and acknowledging this heritage is crucial to conducting ethical research. Collaboration with these communities and ensuring that their knowledge and traditions are honored can prevent exploitation and foster a more inclusive approach to psychedelic research, while enabling cultural nuances to be incorporated into clinical best practices.[9]
Regulatory Challenges in Psychedelic Research
Regulatory frameworks pose another significant hurdle. Psychedelics are classified as Schedule I substances in many countries, including the United States, indicating that they are considered to have no accepted medical use and a high potential for abuse. This classification creates substantial barriers to research, including restrictions on funding, limitations on the supply of research-grade substances, and extensive bureaucratic requirements that can hinder development, delay healing, and ultimately exacerbate existing societal challenges in treating mental health conditions.
The recent FDA advisory committee’s vote against MDMA therapy underscores these regulatory challenges. Despite promising results from clinical trials, the committee cited concerns about study design, including the inability to blind participants and therapists effectively, and the influence of prior MDMA use on trial outcomes. The need for trial participants to not know if they have received the hallucinogenic substance (blinded) is especially important for producing generalizable results with trustworthy data, as awareness of administration can cause participants to alter their behavior and thus skew results. The concerns extended to the psychotherapy protocols used alongside MDMA, which varied and could not be strictly regulated by the FDA. Additionally, allegations of discouraging participants with adverse experiences from follow-up studies have cast a shadow over the credibility of the findings.
However, there are signs of progress. The U.S. FDA has granted “Breakthrough Therapy” designation to both psilocybin and MDMA, facilitating faster development and review processes. Similarly, regulatory bodies in other countries, such as Australia and New Zealand, are beginning to reevaluate their stance on psychedelics, recognizing their potential as therapeutic agents and allowing physicians to prescribe MDMA and psilocybin to treat PTSD and depression.[10] These changes are crucial for advancing research, but they also require careful navigation to ensure that the rush to explore these substances does not outpace the establishment of robust safety and ethical standards.
Collaborative Approaches to Advance Psychedelic Research
The scientific community is forced to remain nimble in its approach to advancing alternative therapy research, and cross-practice collaboration has proven to be a key driver in this field. An interconnected network of researchers is forming at various institutions across the globe, reflecting a collaborative and multidisciplinary approach to exploring psychedelic therapies.[11] This network integrates diverse fields such as psychiatry, neuroscience, palliative care, and law, facilitating a comprehensive understanding of psychedelics. Researchers share common goals, including understanding the neurobiological effects of psychedelics and developing safe, effective treatments for mental health conditions.[12]
Institutional support from places like Yale and Massachusetts General Hospital, along with shared resources and expertise, enhances the quality and scope of research and bolsters philanthropic funding, public interest, and educational initiatives to train future researchers and therapists.[13],[14]
Takeaways
As the research community continues to explore ways to overcome psychedelic research challenges, it must balance the excitement of discovery with the responsibility to conduct studies that are safe, ethical, and respectful of the profound cultural significance of these powerful substances. Communicating scientific advancements and clinical trial outcomes in a clear, objective, accessible manner is essential in navigating regulatory landscapes and gaining public trust. Engaging policymakers with evidence-based insights and advocating for regulatory reforms based on rigorous research can accelerate acceptance and support for these treatments.
Related Insight
Psychedelic Frontiers: Diverse Perspectives on a Mental Health Revolution PART 1
The first installment of the series will explore public perception of these substances, outlining the how stigma and misinformation have hindered their therapeutic success. The series aims to underscore the nuances of communicating psychedelic medicines with vested parties in order to highlight the therapeutic potential of these substances amid the growing mental health crisis.
Related Expertise
[1] “MAPS PBC Publishes Results of Successful Confirmatory Phase 3 Trial of MDMA-Assisted Therapy for PTSD”, Multidisciplinary Association for Psychedelic Studies (September 14, 2023),
[2]Sarah Tedesco, Ganeya Gajaram, Shahzad Chida, Arham Ahmad, Meghan Pentak, Marina Kelada, Layth Lewis, Deepa Krishnan, Carolyn Tran, Oladipo T Soetan, Lawrance T Mukona, and Ayodeji Jolayemi, “The Efficacy of MDMA (3,4-Methylenedioxymethamphetamine) for Post-traumatic Stress Disorder in Humans: A Systematic Review and Meta-Analysis”, Cureus (May 17, 2021), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8207489/
[3] Sara Reardon, “MDMA therapy for PTSD rejected by FDA panel”, Nature (June 5, 2024)
[4] Analee Armstrong, “Lykos’ MDMA treatment rejected by FDA committee, despite being ‘75% of the way there’”, Fierce Biotech (June 5, 2024), https://www.fiercebiotech.com/biotech/lykos-mdma-treatment-rejected-fda-committee-despite-being-75-way-there
[5] US Food & Drug Administration (FDA), “Advisory Committees Give FDA Critical Advice and the Public a Voice”, FDA (June 13, 2024), https://www.fda.gov/consumers/consumer-updates/advisory-committees-give-fda-critical-advice-and-public-voice#:~:text=This%20process%20is%20transparent%20and,legally%20bound%20to%20do%20so
[6] Kenneth W. Tupper, Evan Wood, Richard Yensen, Matthew W. Johnson, “Psychedelic medicine: a re-emerging therapeutic paradigm”, Canadian Medical Association Journal (October 6, 2015), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4592297/
[7] Kimberly Chew, “Conducting Psychedelic Clinical Trials”, Husch Blackwell (June 23, 2023), https://www.huschblackwell.com/newsandinsights/conducting-psychedelic-clinical-trials
[8] Jordan Sloshower, “Challenges in Trial Design for Psychedelic-Assisted Therapies:Reflections from Two Trials of Psilocybin Therapy of Depression”, Massachusetts General Hospital – Psychiatry Academy (November, 2022), https://mghcme.org/app/uploads/2022/11/Sloshower_-final-research-challenges_MGH_11.3.22.pdf
[9] Daniel R. George, Ryan Hanson, Darryl Wilkinson, Albert Garcia-Romeu, “Ancient Roots of Today’s Emerging Renaissance in Psychedelic Medicine”, Springer Nature (September 2, 2021), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8412860/
[10] Rich Haridy, “Australia to prescribe MDMA and psilocybin for PTSD and depression in world first”, Nature (June 30, 2023), https://www.nature.com/articles/d41586-023-02093-8
[11] “Connecting Science and Human Wellbeing”, Usona Institute (2024), https://www.usonainstitute.org/
[12] Allison Eck, “Altering Perceptions on Psychedelics”, Harvard Medicine (Spring 2022) https://magazine.hms.harvard.edu/articles/altering-perceptions-psychedelics
[13] “Yale Psychedelic Science Group”, Yale School of Medicine (2022), https://medicine.yale.edu/psychiatry/education/residency/interest/psychedelic_science_group/
[14] “Center for the Neuroscience of Psychedelics”, Massachusetts General Hospital (2024), https://www.massgeneral.org/psychiatry/treatments-and-services/center-for-the-neuroscience-of-psychedelics
The views expressed in this article are those of the author(s) and not necessarily the views of FTI Consulting, its management, its subsidiaries, its affiliates, or its other professionals.
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